The EMA’s CHMP has maintained its decision not to recommend a marketing authorisation for the orphan medicine Glybera (alipogene tiparvovec).

The Committee again reviewed the benefit risk of Glybera in lipoprotein lipase deficiency patients with severe or multiple pancreatitis attacks.

But it concluded there was insufficient evidence to show the benefit of the gene-therapy in the restricted group of patients and was unable to recommend marketing authorisation.

The European Commission requested in January 2012 that the EMA review its negative opinion confirmed in October 2011. That followed a request from the applicant Amsterdam Molecular Therapeutics B.V. after the CHMP had originally failed to recommend the marketing of the product in June 2011.

Glybera is a gene-therapy product that uses an adeno-associated viral vector intended to treat adult patients diagnosed with lipoprotein lipase deficiency demonstrating hyperchylomicronaemia or who have a history of acute pancreatitis.

But the CHMP found it difficult to obtain and assess data in this very rare disease.

After considering all of the evidence, it concluded that Glybera reduced pancreatitis attacks in the small number of patients assessed, but the evidence was not sufficiently convincing.

In addition, the Committee decided that the reduced risk of pancreatitis attacks may have been due to other factors, such as lifestyle and diet.

The new NHS reforms will make it more difficult to track and remedy health inequalities, according to experts writing in the BMJ.

The fact that CCGs and can take patients from anywhere in the UK threatens the comparative value of their health data, the authors said.

In addition, the fact that they are likely to outsource public health services to the private sector means that data quality and completeness will not be regulated.

Professor Allyson Pollock, Professor Alison Macfarlane and Sylvia Godden argued that the new Health and Social Care Act has “severe implications” for data regarding health needs and access to care.

Although it will be possible to compare the patient populations of the new CCGs, the authors said, “the instability of the denominator population will hinder accurate interpretation of the data”.

Public health services such as childhood vaccination, mental health and sexual health are now the responsibility of local government, which will subcontract them to CCGs – which, in turn, may outsource them to private providers.

As a result, crucial data on unmet needs and access to treatment may not only be sourced in inconsistent ways but be subject to commercial criteria including the confidentiality of business information.

Cancer registries will also be affected, the authors warned, with health data being treated as commercial property rather than as a shared resource.

They concluded: “The abolition of area-based structures and the transfer of most responsibilities to non-geographically based CCGs undermines the availability of information and routine data required to monitor the comprehensiveness of the health service, inequalities in access, the resourcing of services, and outcomes of care.”

As a result, they argued, it will become “almost impossible to take the action needed to tackle inequalities in health and in access to healthcare.”

Watson Pharmaceuticals has entered into a definitive agreement to acquire Actavis for around €4.25 billion to create the third largest global generics company.

The combined company will have commercial operations in more than 40 countries and increase Watson’s international generic net revenues from 16% to 40% to reach around $8bn.

Paul M. Bisaro, President and CEO of Watson, said the acquisition “dramatically enhances” Watson’s commercial positioning and “brings complementary products and capabilities” in the US.

Actavis has more than 10,000 global employees and had revenues last year of around $2.5bn. It markets more than 1,000 products and has approximately 300 products in its pipeline.

“In a single, commercially compelling transaction, we more than double Watson’s international access and strengthen our commercial position in key established European markets as well as exciting emerging growth markets, including Central and Eastern Europe and Russia,” said Paul Bisaro. 

“The transaction achieves Watson’s stated strategic objective of expanding and diversifying our business into a truly global company.  Once the transaction is completed, approximately 40% of our generic revenues will come from markets outside of the US.”

The CEO added that the deal is “financially compelling” and will accelerate Watson’s growth profile for the “foreseeable future”.

When completed, Watson will have more than 17,000 staff around the globe and have around 20 manufacturing facilities and more than a dozen R&D centres. Watson says its enhanced scale will allow it to capitalise on new commercial, R&D, manufacturing and customer service capabilities.

GlaxoSmithKline (GSK) has reported modest global sales growth and significant pipeline development in the first quarter of 2012.

The UK’s largest pharmaceutical company achieved 2% sales growth worldwide despite a 6% drop in European sales.

The company also highlighted positive phase III data for five assets in treatment of major diseases, pointing the way to future growth.

CEO Andrew Witty said that GSK had “returned to reported sales growth, delivered additional R&D pipeline output and maintained our focus on returns to shareholders” in Q1.

GSK’s performance “reflects the resilience of our business and the investments we have made to increase the breadth and mix of the Group,” he commented.

The company’s pharmaceuticals and vaccines business grew by 2% overall – due largely to 9% growth in the US, where a co-promotion deal for overactive bladder treatment Vesicare combined with successful product launches in oncology.

However, Witty noted that pharmaceuticals and vaccines sales fell by 6% in Europe due to “the continued implementation of government austerity measures”.

The EMAP market saw 2% growth in this product area, with pharmaceuticals up 6% but vaccines down 9%, and strong sales in China and Latin America compensating for the impact of political turmoil in Africa and the Middle East.

Witty emphasised that GSK’s future lies in its pipeline, echoing the recent words of Lilly CEO John Lechleiter. He pointed to positive results for five drug candidates:

• The first of three phase III studies for HIV drug dolutegravir, showing non-inferiority to raltegravir.

• Successful phase III studies for melanoma drugs BRAK and MEK, which are ready to be filed for approval (and to be trialled in combination).

• Ongoing successful phase III data for type 2 diabetes drug albiglutide.

• Completion of phase III studies of asthma and COPD treatment Relovair, which will be filed for both indications this summer.

These new products, Witty said, “together with the progress we have made with the broader late-stage pipeline since the beginning of 2011, underpins our growing confidence in our ability to grow sales on a sustainable basis.”

For a video interview with GSK’s CFO, Simon Dingemans, click here.

GlaxoSmithKline (GSK) has reported modest global sales growth and significant pipeline development in the first quarter of 2012. CFO Simon Dingemans answers questions about GSK’s current position and expectations for the future.

To read the whole story, click here.
 

David Brennan is to retire from his position as Chief Executive Officer and board member of AstraZeneca after more than six years in the role.

Pressure has been growing on the 59-year-old to depart after major shareholders questioned his leadership in the face of generic competition on several leading brands.

Mr Brennan says he is proud of his achievements as CEO and that it has been a “genuine privilege” to lead the company.

He will retire on 1 June 2012 with Executive Director and Chief Financial Officer Simon Lowth acting as interim CEO until a permanent successor has been found.

The departing Mr Brennan admits the pharmaceutical sector is “experiencing pressures none of which I’ve witnessed in my 36 years in the industry”. But he says he remains “very confident” that AZ has the “capabilities, courage and determination to be successful into the future”.

“If we maintain our focus on meeting the needs of patients and trying to solve unmet patient needs, we can continue to deliver attractive and sustained returns for our shareholders,” he said.

Mr Brennan outlined that during his six years as AZ’s leader the company has developed some of the “world’s leading products” and “established a position” in emerging markets. He said AZ had “re-shaped R&D” and “returned considerable value to shareholders”.

He added during his reign that the London-based company had “tried to lead the debate on restoring trust” in the pharma industry through the introduction of a “bold policy on interactions with healthcare professionals”.

His decision to retire was revealed on the same day AZ posted its Q1 results for 2012 – which saw profits fall by 38% and revenue drop by 11% as the company faced generic competition on a number of key products.

AstraZeneca saw revenue fall by 11% in the first quarter of 2012 after generic competition hit the company hard.

Sales amounted to $7.349 billion after several key brands lost exclusivity, which accounted for an 8% decline in revenue. Reported operating profit, profit before tax and earnings per share were also down by more than a third.

David Brennan, Chief Executive Officer, says the “anticipated impact” of generic competition “has made for a difficult start to the year”.

Revenues were down in the US (12%), Western Europe (21%) and in Established Rest of the World (6%) and Emerging Rest of the World (1%); however, emerging markets did see a 1% increase.

In the US, revenue was down from $3.3bn in Q1 2011 to $2.9bn in the same period this year. Generic competition on Seroquel IR accounted for $223 million of the $384m loss. Growth was recorded for Onglyza, Seroquel XR and Symbicort. However, this was offset by a decline in sales of Nexium and a loss of protection for Toprol-XL, Arimidex and Merrem.

Sales were down further in Western Europe where generic competition for Nexium, Arimidex and Merrem accounted for nearly 60% of lost revenue. In Japan sales were down by a tenth, and in Canada by 8%.

An increase in revenue in China by 13% helped sales increase in emerging markets as AZ again faced the loss of patent protection for Crestor and Seroquel in Brazil and government interventions in price in Turkey.

AZ also lost $702 million in restructuring costs in Q1 as it undertook the third phase of the $2.1bn efficiency programme it revealed in February 2012. It anticipates that total restructuring costs will be absorbed this year in order to save $1.6bn by the end of 2014.

The disappointing results were published on the same day that David Brennan revealed plans to retire from his position on 1 June 2012.

Ana Nicholls, Analyst, Economist Intelligence Unit, says his decision to stand down is no real surprise. “Investors have long been dissatisfied with AstraZeneca’s efforts to cope with these challenges, despite its efforts to keep them onside,” she commented.

“Managers are aware they also need to step up their expansion into emerging markets that hold better growth prospects. Given this, and AstraZeneca’s fairly health cash pile, the company is under pressure to make acquisitions to help sustain growth – it is Mr Brennan’s failure to do this that has forced him into retirement.”

As a result of the Q1 figures, AstraZeneca readjusted its 2012 outlook and expects the decline in revenue will be in the range of the low to mid-teens.